Project(Summary(/(Abstract( The abuse of prescription drugs is the fastest-growing drug problem in the United States, and reducing such abuse is a national priority. In 2014, prescription opioids caused 18,893 overdose deaths in the United States, according to the American Society of Addiction Medicine. The best way to defeat an epidemic is to reduce exposure. In this case, the challenge is to reduce exposure without compromising patient care. This calls for a balanced solution that addresses both the individual patient's needs and the national opioid epidemic. Elysium?s O2P (oral overdose protection) technology is designed to provide such a balanced solution by taking advantage of the well-established efficacy of existing opioids, while protecting against abuse and fatal overdose. Using novel chemistry, we have created a new class of immediate-release (IR) oral opioids that offer an attractive alternative to the widely-prescribed Vicodin, Percocet, Lortab, Norco, etc. with superior tamper resistance and unprecedented protection from oral overdose that could: Save thousands of lives each year; Disrupt the heartbreaking and often lethal progression from the misuse and abuse of prescription opioids, to heroin use and addiction; and Provide safe pain relief to patients throughout the world that currently do not have access to effective opioid-based pain therapy due to fears relating to abuse and overdose. With NIH and NIDA?s support (1R44DA037900), Elysium has successfully achieved in vivo proof-of-concept. The overall goal of this proposed grant is to collaborate with a Strategic Alliance of highly qualified CROs and scientific advisers to accelerate development of our O2P IR hydrocodone product candidate through Phase 1 human proof of concept studies, a pivotal step toward advancing our lead toward FDA approval, and a commercialization deal with a larger pharmaceutical company.